Uses of Hepatitis A and Hepatitis B Recombinant Vaccine

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Consumer Information Use and Disclaimer

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Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take hepatitis A and hepatitis B recombinant vaccine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to hepatitis A and hepatitis B recombinant vaccine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Pharmacology

Hepatitis A vaccine, an inactivated virus vaccine, offers active immunization against hepatitis A virus infection at an effective immune response rate in up to 99% of subjects.

Recombinant hepatitis B vaccine is a noninfectious subunit viral vaccine. The vaccine is derived from hepatitis B surface antigen (HBsAg) produced through recombinant DNA techniques from yeast cells. The portion of the hepatitis B gene which codes for HBsAg is cloned into yeast which is then cultured to produce hepatitis B vaccine.

In immunocompetent people, Twinrix provides active immunization against hepatitis A virus infection (at an effective immune response rate >99% of subjects) and against hepatitis B virus infection (at an effective immune response rate of 93% to 97%) 30 days after completion of the 3-dose series. This is comparable to using hepatitis A vaccine and hepatitis B vaccine concomitantly.

Usual Adult Dose for Hepatitis A Prophylaxis

Primary immunization: 1 mL IM in the deltoid area at 0, 1 and 6 months. Alternatively, a 4 dose schedule given on days 0, 7, and 21 to 30 followed by a booster at month 12 may be used.

Precautions

The safety and efficacy of hepatitis A-hepatitis B vaccine has not been established in children < 18 years.

Hepatitis A-hepatitis B vaccine is contraindicated in patients who have had signs of hypersensitivity after a previous dose of this vaccine or of the monovalent vaccines, or who are allergic to yeast or other trace substances (thimerosal, neomycin) which may be present in the vaccine.

The cap and plunger of the prefilled syringes contain latex, which may cause allergic reactions in sensitive patients.

Hepatitis A and B have long incubation periods. This vaccine may not prevent infection in persons with unrecognized infection at time of vaccination.

Anaphylaxis may occur, even in patients with no previous hypersensitivity to the vaccine ingredients. Epinephrine and other medications and equipment should be readily available to treat anaphylactic or severe allergic reactions.

Delaying vaccination should be considered if the patient has a moderate or severe acute illness. Minor illnesses such as mild upper respiratory tract infections with or without low grade fever are not considered contraindications to vaccination.

Caution is recommended in patients with thrombocytopenia or coagulation disorders that would contraindicate intramuscular injection.

The expected immune response may not occur in immunosuppressed patients. It may be advisable to defer vaccination for at least 3 months after immunosuppressive therapy.

Hepatitis A-hepatitis B vaccine is only intended for intramuscular administration. Injection into a blood vessel should be avoided.

Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).

There are no data on the excretion of hepatitis A-hepatitis B vaccine into human milk. The manufacturer recommends that caution be used when administering the vaccine to nursing women. The U.S. Centers for Disease Control and Prevention (CDC) consider the administration of inactivated virus vaccines compatible with breast-feeding.

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